Univasc

INDICATIONS

univasc® is indicated for treatment of patients
with hypertension. It may be used alone or in combination with thiazide
diuretics.

In using univasc®, consideration should be given
to the fact that another ACE inhibitor, captopril, has caused agranulocytosis,
particularly in patients with renal impairment or collagen-vascular disease.
Available data are insufficient to show that univasc® does not have
a similar risk (see WARNINGS).

In considering use of univasc®, it should be
noted that in controlled trials ACE inhibitors have an effect on blood pressure
that is less in black patients than in non-blacks. In addition, ACE inhibitors
(for which adequate data are available) cause a higher rate of angioedema in
black than in non-black patients (see WARNINGS, Angioedema).

DOSAGE AND ADMINISTRATION

Hypertension

The recommended initial dose of univasc® in
patients not receiving diuretics is 7.5 mg, one hour prior to meals, once
daily. Dosage should be adjusted according to blood pressure response. The antihypertensive effect of univasc® may diminish towards the end of
the dosing interval. Blood pressure should, therefore, be measured just prior
to dosing to determine whether satisfactory blood pressure control is obtained.
If control is not adequate, increased dose or divided dosing can be tried. The
recommended dose range is 7.5 to 30 mg daily, administered in one or two
divided doses one hour before meals. Total daily doses above 60 mg a day have
not been studied in hypertensive patients.

In patients who are currently being treated with a diuretic,
symptomatic hypotension may occasionally occur following the initial dose of
univasc®. The diuretic should, if possible, be discontinued for 2 to
3 days before therapy with univasc® is begun, to reduce the
likelihood of hypotension (see WARNINGS). If the patient's blood pressure is
not controlled with univasc® alone, diuretic therapy may then be
reinstituted. If diuretic therapy cannot be discontinued, an initial dose of
3.75 mg of univasc® should be used with medical supervision until
blood pressure has stabilized (see WARNINGS and PRECAUTIONS: DRUG INTERACTIONS).

Dosage Adjustment in Renal Impairment

For patients with a creatinine clearance ≤ 40
mL/min/1.73 m², an initial dose of 3.75 mg once daily should be given
cautiously. Doses may be titrated upward to a maximum daily dose of 15 mg.

HOW SUPPLIED

univasc® (moexipril hydrochloride) 7.5 mg tablets
are pink colored, biconvex, film-coated and scored with engraved code 707 on
the unscored side and SP above and 7.5 below the score. They are supplied as
follows:

univasc® (moexipril hydrochloride) 15 mg tablets
are salmon colored, biconvex, film-coated, and scored with engraved code 715 on
the unscored side and SP above and 15 below the score. They are supplied as
follows: